KleenGel Dispenser
FDA 510(k) K143177 · Kleengel, LLC
510(k) numberK143177
Submission
- Device name
- KleenGel Dispenser
- Applicant
- Kleengel, LLC
Boca Raton, FL, US - Received
- November 4, 2014
- Decision date
- September 14, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KYX – Dispenser, Liquid Medication
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6430
- Specialty
- General Hospital
Other 510(k)s with product code KYX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K980109 | Cyclotech Cyclosporine Oral Solutions DispenserKYX · Traditional | Sangstat Medical Corp. | 08/18/1998SE |
| K954181 | Canyons Bi-Directional Check ValveKYX · Traditional | Canyon Medical Products | 11/29/1995SE |
| K830571 | Bottle AdapterKYX · Traditional | Burron Medical Products, Inc. | 03/24/1983SE |
| K801008 | Multi-Ad Fluid Dispensing Pump MP-3000KYX · Traditional | Burron Medical Products, Inc. | 06/02/1980SE |
| K800437 | Syringe Tip ConnectorKYX · Traditional | Burron Medical Products, Inc. | 03/12/1980SE |
| K800362 | Fluid Dispensing SystemKYX · Traditional | Pharmaseal Laboratories | 03/12/1980SE |
| K792227 | Multi-Ad Fluid Dispensing SystemKYX · Traditional | National Patent Development Corp. | 12/20/1979SE |
| K781364 | Pint Bottle WellKYX · Traditional | Baxa Corp., Sub. of Cook Group, Inc. | 10/17/1978SE |
| K771539 | StepperKYX · Traditional | Tridak | 10/07/1977SE |
| K760517 | Cup, Disposable MedicineKYX · Traditional | Landmark Plastics | 11/12/1976SE |
Questions and answers
When was KleenGel Dispenser cleared by the FDA?
KleenGel Dispenser (K143177) received a 510(k) decision of Substantially Equivalent on September 14, 2015, 314 days after the submission was received.
What is the product code of K143177?
The FDA product code is KYX – Dispenser, Liquid Medication, a Class I (low risk) device regulated under 21 CFR 880.6430.